4. Examples of the benefit, harm and potential of non-drug interventions

Newborns are physically examined immediately after birth using simple tests. In the process, certain serious heart defects may go undetected and become life-threatening. Pulse oximetry is designed to identify these heart defects. It uses a light sensor attached to the newborn's foot to measure the oxygen level in the blood. Low oxygen levels may indicate a critical congenital heart defect. The exam is painless and no blood needs to be drawn. It takes only a few seconds and shows the result immediately. The question was whether the technique, in addition to standard screening, could help detect previously undetected serious heart defects, thus preventing more severe or fatal courses.

IQWiG identified six studies to answer the question as to whether pulse oximetry has a benefit as a screening test. Among them was an intervention study in which pulse oximetry was performed in addition to the established procedure and this combination was compared with the established procedure alone. Although this study provided indications of a benefit of the technique, for methodological reasons it was insufficient to clearly demonstrate benefit. Five further studies were therefore considered that investigated the test accuracy of pulse oximetry, but not its benefit or harm.

All in all, the assessment showed that on average pulse oximetry screening detects previously undetected congenital heart defects in 3 out of 10 000 newborns examined. While there are also false-positive findings, most of these cases are due to other health problems detected in this way.

Based on these results, IQWiG concluded that the data provided hints of a benefit of pulse oximetry screening, so that the G-BA decided that pulse oximetry should be included as an additional examination in the screening of newborns and that the costs should be covered by the SHI.

Since the mid-2000s, this is a procedure in which stents - small tubes made of wire mesh - are used to prevent strokes in certain patients who have already suffered a stroke.

If blood vessels in the brain are narrowed or blocked, this can trigger a stroke, meaning that the area of the brain behind them is no longer supplied with oxygen and is damaged. The risk of stroke is increased in patients who previously suffered a stroke. To reduce the risk of these patients having another stroke, they are given drugs that inhibit blood clotting ("blood thinners") during follow-up care, and the narrowed vessels are often dilated with the help of a small balloon (percutaneous transluminal angioplasty, PTA). To prevent recurrence, the procedure has been extended by additionally inserting a stent as a vascular support to keep the dilated blood vessel open (percutaneous transluminal angioplasty with a stent, PTAS).

Because major doubts about the benefit of stents had arisen following study results, the G-BA commissioned IQWiG in 2014 to assess PTAS in intracranial stenosis compared with treatment with blood-thinning drugs alone or drugs plus vasodilation by balloon (PTA). Every year, about 500 patients in Germany received such a PTAS.

IQWiG's identified four relevant studies, but one large randomized controlled trial (RCT) was particularly relevant. In this study, PTAS was performed in more than 200 patients, while more than 200 patients in the control group received drug-only treatment.

The comparison between drug-only treatment and the PTAS procedure with stents was clear: significantly more patients suffered a stroke in the stent group than in the drug-only group. The data also provided indications that these strokes were triggered by the insertion of the stents, as they occurred more frequently shortly after the procedure.

Thus, according to IQWiG, the data provide a hint of harm. The assessment result was not clearer because there could have been bias in the results of the study included (due to deaths and strokes the study was terminated prematurely, i.e. did not run for the prespecified period). Because the G-BA considered a quick decision important in view of the disturbing study results, IQWiG prepared a rapid report. When results from another large study were published a short time later, IQWiG immediately provided a further assessment. Here, too, PTAS was shown to be disadvantageous.

Based on the IQWiG assessments, the G-BA finally decided in 2016 to exclude stents from SHI coverage for prevention of recurrent stroke (except in few exceptional cases).

As early as in 2014, the G-BA commissioned IQWiG to assess the potential of a procedure used for the treatment of retinopathia pigmentosa. This relatively rare form of retinal degeneration is inherited or arises from a spontaneous mutation. The photoreceptors gradually die off. Symptoms include night blindness, poor adaptation of the eyes to changing light conditions, sensitivity to glare, restricted field of vision, impaired contrast vision, colour deficiency and loss of visual acuity. Finally, most patients lose their vision completely. Until now, it has not been possible to offer patients any treatment. In transcorneal electrical stimulation, the retina is stimulated with a weak electrical impulse.

The IQWiG assessment demonstrated that the procedure has potential. A corresponding testing directive came into force in 2017. The G-BA then initiated a testing study, which started in 2021 and is expected to be completed in early 2026.